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The EcoFit®, implaFit® and BethaLoc® hip stems are indicated for use in cases of:
· Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis;

• · Rheumatoid arthritis;
  · Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable by other techniques; and
  · Revision of previously failed total hip arthroplasty.

The EcoFit®, implaFit® and BethaLoc® hip stems, when used in conjunction with the ic-Bipolar Heads, are intended for the following indications:
· Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis

• Rheumatoid arthritis
• · Correction of functional deformity
  · Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.

The EcoFit® hip stems, the implaFit® hip stems cementless and the BethaLoc® hip stems are intended for uncemented, press-fit fixation.

The implaFit® hip stems cemented are intended for cemented fixation.

The ic-Bipolar Head System is intended for uncemented use in hemiarthroplasty, where the femoral head requires replacement but the acetabulum does not, in conjunction with the BethaLoc® hip stems and EcoFit® Hip System for the following indications:
· Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis

• Rheumatoid arthritis
• · Correction of functional deformity
  · Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.

The purpose of this Traditional 510(k) is introduce into interstate commerce in the United States the BethaLoc® hip stems. The BethaLoc® hip stems are femoral stems for total or hemi hip arthroplasty. The BethaLoc® hip stems are available in standard and lateralized offset configurations. The BethaLoc® hip stems are monoblock, tapered straight stems made from titanium alloy with a partial coating of hydroxyapatite (HA). They are fixed by press-fitting. The BethaLoc® hip stems are intended to be used with previously cleared EcoFit® Hip components.

This is a 510(k) summary for a medical device (hip stems), not an AI/ML device. Therefore, the requested information regarding AI/ML acceptance criteria, study details, human reader improvement with AI assistance, and training/ground truth datasets is not applicable and cannot be extracted from the provided text.

The document discusses the substantial equivalence of the "BethaLoc® stem cementless HA" device to legally marketed predicate devices. The performance testing section details the physical and biological tests performed on the device to ensure its safety and effectiveness, but these are engineering and biocompatibility tests, not studies related to AI/ML performance.

Therefore, I cannot provide a response that directly answers your prompt as it pertains to AI/ML device evaluation.

If you are looking for information on the acceptance criteria and performance studies for a hip stem (non-AI/ML), the document indicates the following:

1. Table of acceptance criteria and reported device performance:

The document states that "All performance testing conducted for the BethaLoc® hip systems met the predetermined acceptance criteria or were otherwise considered acceptable." Specific numerical acceptance criteria or performance metrics are not explicitly provided in a table format within this summary, but the types of tests performed are listed.

Regarding the AI/ML specific questions (2-9), the document does not contain this information as it describes a non-AI/ML medical device.

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Exprt™ Revision Hip System is indicated for patients whose bone stock is of poor quality or inadequate for other reconstruction techniques as indicated by deficiencies of the femoral head, neck or portions of the proximal femur. It is intended for cementless revision hip arthroplasty on both uncemented and cemented femoral implants.

The EXPRT™ Revision Hip System includes non-porous distal femoral stem implants and nonporous proximal body implants, with bolt, all made from titanium alloy (Ti6Al4V) per ASTM F1472. System specific instrumentation allows the surgeon to prepare the bone to accept the EXPRT™ Revision Hip System implants.

This document is a 510(k) summary for the EXPRT™ Revision Hip System, a medical device. It does not describe an AI/ML medical device, and therefore the requested information regarding acceptance criteria and a study proving the device meets those criteria, particularly in the context of AI/ML performance metrics, is not present.

The document is a regulatory submission for a traditional medical device (a hip replacement system). The "acceptance criteria" and "study" mentioned here refer to the non-clinical and pre-clinical testing required for substantial equivalence, not performance metrics for an AI algorithm.

Here's a breakdown of why the requested information cannot be extracted from this document:

• No AI/ML Component: The device is a physical hip implant (EXPRT™ Revision Hip System). There is no mention of any AI or machine learning component.
• "Acceptance Criteria" Context: For a physical device like a hip implant, "acceptance criteria" typically relate to mechanical strength, biocompatibility, material properties, and manufacturing quality, not diagnostic performance or AI model accuracy.
• "Study" Context: The document mentions "Non-Clinical Testing: ROM testing and distal fatigue testing," and "Endotoxin Assessment," which are standard tests for orthopedic implants to determine their mechanical integrity and safety. It explicitly states, "Clinical Testing: Clinical testing was not required." This indicates that the substantial equivalence was based on non-clinical data comparing it to existing predicate devices.

Therefore, it is impossible to provide the requested information in the format specified because it pertains to an AI/ML context that is not applicable to this document.

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